Devices and methods for suturing a cardiac implant

ABSTRACT

Described herein are reusable surgical needles having a resiliently collapsible rear loop that captures a suture as it is passed through an object and resiliently expands upon exiting the object to release the suture. Also described are suture spool assemblies that comprise a rigid housing and a rotatable spool of suture material suspended within the housing so that a plurality of sutures can be dispensed from the assembly in succession during a surgery. Also described are annular pledgets having diametrical dimensions similar to an outer ring of a cardiac implant such that a single annular pledget can be used with a plurality of sutures that secure the cardiac implant to native tissue around the perimeter of the cardiac implant. Related methods of suturing cardiac implants are also disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/326,567, filed Jan. 16, 2017, now U.S. Pat. No. 10,555,732, which isa U.S. National Stage of International Application No.PCT/US2015/040782, filed Jul. 16, 2015, which claims the benefit of U.S.Patent Application No. 62/025,117, filed Jul. 16, 2014, all of which areincorporated by reference herein in their entireties for all purposes.

FIELD

Described herein are devices and methods for suturing a cardiac implantusing a surgical needle.

BACKGROUND

Needles are frequently used with a needle driver in many differentsurgical procedures, such as to close vascular tissues, during anaortotomy, and during heart valve surgery. These needles typically havea size and shape that is customized for each particular procedure. Suchcustomized needles can be very expensive. During procedures, a surgeonoften uses several different types of needles and sutures for differentaspects of the procedure. The needles are typically used with one ormore small reinforcing pledgets for each suture. The pledgets providemore resistance to the sutures and protect against the sutures cuttingthe tissue. However, during surgery, a suture occasionally breaks orpulls out of the needle, and as a consequence a pledget for that suturecan come loose and can get lost inside the patient. During a cardiacvalve replacement, for example, a surgeon may place 12-18 sutures withinthe native valve annulus, with each suture having a respective needleand its own respective pledget. The surgeon then drives each needle andrespective suture through and anchorage part of the implant. Since eachof the sutures is applied using a different needle, the cost of placing12-18 sutures includes 12-18 times the cost of one needle.

SUMMARY

The disclosed devices and methods can reduce the total cost of theneedles by using the same needle for all or many of the sutures, caneliminate or reduce the risk of losing pledgets within the patient'sbody, and/or can provide an alternative and easier way to place theneedle/sutures within the tissue and cardiac implants.

An exemplary suture needle includes an elongated rigid body having asharp front end for piercing and a flexible looped portion coupled tothe rear end the rigid body. In some embodiments, the looped portioncomprises four substantially linear segments linked together end-to-endwith three bends joining the four linear segments such that the loopedportion has a generally quadrilateral shape in an open configuration.The looped portion is resiliently collapsible from the openconfiguration to a collapsed configuration such that the surgical needleis adapted to capture a suture in the looped portion in the collapsedconfiguration while the surgical needle is drawn through a targetobject. The looped portion is then resiliently expandable from thecollapsed configuration back to the open configuration, such that thesurgical needle is adapted to release the captured suture from thelooped portion after the surgical needle has drawn the suture through atarget object.

An exemplary suture spool assembly comprises a rigid outer housing andat least one spool of suture material suspended within the outer housingsuch that the spool is free to rotate relative to the outer housingabout a central axis of the spool. For each spool, the housing caninclude a suture outlet through which a free end of the suture materialon the spool extends, such that tension on the free end of the suturematerial causes the spool to rotate and dispense the suture materialfrom the spool through the suture outlet. The assembly can include twoor more spools that each hold different kinds of suture material suturematerials. The housing can be opened and closed to insert, remove andreplace the spools.

Also described herein are annular pledgets having diametrical dimensionssimilar to an outer anchorage ring of a cardiac implant such that asingle annular pledget can be used with the plurality of sutures thatsecure the cardiac implant to native tissue around the perimeter of thecardiac implant.

An exemplary method of securing a cardiac implant comprises dispensing afirst suture from a suture spool assembly, inserting the first suturethrough an opening in a surgical needle, passing the surgical needle andfirst suture through a first native tissue implant location, passing thesurgical needle and first suture through an annular pledget, passing thesurgical needle and first suture through an outer anchorage portion of acardiac implant, and securing the cardiac implant to the first nativetissue implant location using the first suture, with the annular pledgetpositioned between the first native tissue implant location and theouter portion of a cardiac implant. The method can further includereusing the same needle to apply one or more additional sutures thatsecure the surgical implant to one or more respective additional nativetissue locations, wherein the additional sutures pass through the sameannular pledget. A single annular pledget can be used that has roughlythe same diametrical dimensions as the outer anchorage portion of thecardiac implant.

The foregoing and other objects, features, and advantages of thedisclosed technology will become more apparent from the followingdetailed description, which proceeds with reference to the accompanyingfigures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an exemplary surgical needle with a straight body and acurved looped end.

FIG. 2 shows an exemplary surgical needle with a curved body and acurved looped end.

FIG. 3 shows an exemplary surgical needle with a curved body and afour-sided looped end.

FIG. 4 shows an exemplary surgical needle with a straight body andslotted end.

FIG. 5 shows an exemplary surgical needle passing a suture through anexemplary cardiac implant.

FIG. 6 shows an exemplary annular pledget.

FIG. 7 is a top view of an exemplary cardiac implant with two pairs ofsutures passing through its outer body.

FIG. 8 is a schematic cross-sectional side view of an exemplary suturespool assembly, showing an internal suture spool and a suture passingfrom the spool through an aperture out of the assembly.

FIG. 9 is a perspective view of the suture spool assembly of FIG. 8.

FIG. 10 is a side view of the suture spool assembly of FIG. 8.

FIG. 11 is an exploded perspective view of the suture spool assembly ofFIG. 8.

FIG. 12 is an exploded side view of the suture spool assembly of FIG. 8.

DETAILED DESCRIPTION

FIG. 1 shows an exemplary needle 2 that comprises a body 4 with a sharpdistal tip 6 at a distal or lead end and a loop 8 extending from theproximal or rear end. The body 4 can be solid or tubular, and can bemade from any sufficiently strong material, such as stainless steel. Insome embodiments, the body 4 is made from a sharpened solid wire, and inother embodiments the body 4 is made from a hypotube with a beveled tip.The body 4 can have a diameter and length selected to match theapplication for which it is intended. In one example, the body 4 canhave an outer diameter of about 0.025 inch and a length of about 1.0inch. The distal tip 6 can be beveled or otherwise sharpened to a pointfor puncturing tissue and an implant. The loop 8 can have a rounded,generally teardrop shape as shown in FIG. 1. The loop 8 can comprise athin, flexible, resilient strand, such as a stainless steel wire, or cancomprise other thin, strong, resilient material, such as polymericmaterial. The loop 8 can be attached to the body 4 in any secure manner,such as by welding (e.g., laser welding) or bonding the ends of the loopdirectly to the body, or by inserting ends of the loop into a hole orcavity in the proximal end of the body (e.g., with a tubular body or asolid body) and crimping the proximal end of the body onto the ends ofthe loop.

The loop 8 receives a suture (or sutures) such that the needle 2 canpenetrate through tissue, a valve frame, sewing cuff, or other componentof a prosthetic device, and carry the suture through the device. Whenthe loop 8 passes through tissue or another object, the loop 8 collapsesand grips the suture securely, preventing the suture from sliding out.The loop 8 can resiliently re-expand, at least partially, back to itsoriginal teardrop shape after passing through an object to release thesuture and reload a new suture.

FIG. 2 shows another exemplary needle 10 comprising a curved body 12with a sharp distal tip 14 at the distal end and a loop 16 extendingfrom the proximal end. The needle 10 is similar to the needle 2, exceptthat the body 12 is curved. The curved body 12 can have any degree ofcurvature. For example, the body 12 can form a semi-circle, or a quarterof a circle, or other arcuate shapes.

FIG. 3 shows another exemplary needle 20 comprising a curved body 22with a sharp distal tip 24 at the distal end and a loop 26 extendingfrom the proximal end. The loop 26 includes substantially straight sidesextending between angled bends 28 and 30, forming a generally diamondshape or kite shape. This shape can help the loop 26 re-open afterpassing through a narrow passage, such as after passing through a valveframe or sewing cuff. The two bends 28 can remain separated from eachother even after the loop 26 has plastically deformed and collapsed tosome degree following several passes through a valve frame or otherobject. Such resilient separation can allow a surgeon to continue torethread sutures through the loop 26 over and over again until thesurgery is complete, reusing the single needle for each suture. Manyother loop shapes and configurations can also be used in otherembodiments. In alternative embodiments, the rigid body 22 can bestraight or can any other suitable curvature.

In general, a surgical needle can comprise an elongated rigid bodyhaving a sharp front end for piercing and a rear end, and a loopedportion coupled to the rear end the rigid body. The looped portion cancomprise four substantially linear segments linked together end-to-endwith three bends joining the four linear segments such that the loopedportion has a generally quadrilateral shape in an open configuration.The looped portion is resiliently collapsible from the openconfiguration to a collapsed configuration where the four linearsegments are generally parallel and extending linearly from the rear endof the rigid body, such that the surgical needle is adapted to capture asuture between the four linear segments in the collapsed configurationwhile the surgical needle is drawn through a target object, such as apledget and/or a cardiac implant. The looped portion is also resilientlyexpandable from the collapsed configuration back to the openconfiguration, such that the surgical needle is adapted to release thecaptured suture from between the four linear segments after the surgicalneedle has drawn the suture through a target object.

In some embodiments, the looped portion has a generally kite-shapedformation in the open configuration (like the shape shown in FIG. 3),wherein a first two of the four linear segments have substantially thesame length, and a second two of the four linear segments havesubstantially the same length, but the first two linear segments have adifferent length than the second two linear segments. In someembodiments, the three bends in the looped portion each define aninterior angle between the linear segments joined by the respectivebend, and when the looped portion is in the collapsed configuration, afirst of the three bends (e.g., bend 30 in FIG. 3) has an interior anglethat is less than 10°, such as near 0°, and the other two of the threebends (e.g., bends 28 in FIG. 3) have an interior angle that is greaterthan 170°, such as near 180°.

FIG. 4 shows is a schematic side view of another exemplary needle 40that comprises a sharp distal tip 42 and an angled slot 44 adjacent theproximal end for receiving a suture. The slot 44 can extend proximallyfrom a lateral opening 46 such that a suture in the slot is restrictedfrom exiting the slot while the needle 40 is passed through an objectand the object applies proximally directed forces on the suture. In somesuch embodiments, the lateral opening 46 can be plastically closed afterinserting a suture into the slot, and manually re-opened to release thesuture and load another suture. The ability to load and remove a suturethrough laterally into and out of the slot 44 can obviate the need tothread an end of the suture through a loop, eyelet, or other enclosedopening to load and remove the suture. This can save time during theprocedure and can allow the needle 40 to be applied onto or removed froma suture when neither end of the suture is free, such as with a loopedportion of a suture or a suture with both ends extending into tissue orother objects.

FIG. 5 shows an exemplary needle 52 (similar to the needle 2 in FIG. 1)passing through an outer annular portion of a cardiac implant 50 (e.g.,a sewing ring of a prosthetic heart valve) while loaded with a suture54. The suture 54 passes through a proximal loop portion of the needle52 while a sharpened distal end has already puncture the implant 50.FIG. 7 shows the exemplary cardiac implant 50 from a top view afterseveral sutures 54 have been threaded through it. Any of the needlesdisclosed herein can be loaded with a variety of different types ofsutures. For example, the sutures can vary in material, size, and/orcolor.

FIG. 6 shows an exemplary pledget 60 that can be used in place of aplurality of smaller individual pledgets. The pledget 60 comprises anannular body with a central opening 62. The annular body of the pledget60 can be sized to correspond with the diameter of a particular cardiacimplant, such as the cardiac implant 50 in FIG. 5, with the centralopening 62 being aligned with the flow pathway through the cardiacimplant. The pledget 60 can be placed along the lower surface of theimplant such that a plurality of sutures (e.g., all 12-18 sutures) canpass through the single pledget 60 and then through the cardiac implant.If one of the sutures breaks or comes loose, the pledget 60 is stillretained by the other sutures and it is less prone to become lost insideof the patient like individual smaller pledgets for each suture. Thepledget 60 can be made of any suitable material (e.g., Teflon®) and canhave any shape and size to correspond with the suture pattern for aparticular implant. For example, the pledget may have a D-shape for amitral valve implant.

FIGS. 8-12 illustrate an exemplary suture spool assembly 70 that can beused to contain and dispense sutures for quick and easy access duringimplantation of cardiac implants. The assembly 70 can comprise a housing72 that forms a handle portion 74 at one end and houses one or morespools 78 of sutures. A cap 76 can close off the opposite end andinclude an opening 82 to allow the suture 80 to extend out of theassembly to be dispensed. The cap 76 can include a blade or othercutting element to cut the suture when a desired length has been pulledout. As shown in FIGS. 9 and 11, the cap 76 can be secured to thehousing 72 via fasteners (e.g., screws) passing through openings 84 and88.

As shown in FIGS. 11 and 12, at least one spool 78 can be mounted withina cavity 86 inside the housing 72. Each spool 78 can include an outerbody 96 that does not rotate relative to the housing 72 and an innerbody 92 that rotates within the outer body about an axle 94. The innerbody 92 can be loaded with the suture material and the leading end ofthe suture material can pass through an opening 90 in the outer body 96and out through the opening 82 in the cap 76 to be dispensed. Inembodiments having more than one spool, the spools can be orientedside-by-side and the cap 76 can include a corresponding number ofopening 82 to dispense each different suture from. Each different sutureand/or the spools themselves can have a different color for visualidentification. In some embodiments, the plural spools can share acommon rotation axle, with in other embodiment, individual axles areincluded. Each spool can be winded with any length of suture material,such as about 10-30 feet, or about 20-25 feet, of suture material. Thetotal length on the spool can be sufficient to supply material for allthe sutures needed to complete a given procedure. The cap 76 can beeasily removed and replaced to load, remove, or swap out the spools.

During surgery, the user can dispense a length of suture material fromthe suture spool assembly 70 for a first suture, cut the suture materialto the desired length, insert the suture material into the needle, passthe needle and suture through the tissue where the cardiac implant is tobe secured, pass the needle and suture through the pledget and thecardiac implant, release the suture from the needle, secure the sutureto secure the implant to the tissue, then repeat the process for eachsuture location using the same needle for each suture.

The disclosed devices, systems, and methods can be used with varioustypes of sutures, threads, cords, wires, cables, lines, filaments, orsimilar objects (which are collectively referred to herein as “sutures”for ease of description). Exemplary suture materials can includebiological tissues (e.g., collagen-based tissue), polyglycolide,polydioxanone, polyester, nylon, polypropylene, and other polymericmaterials. Some sutures comprise several strands of fibers braided orwoven together. Any suitable materials can be used in the constructionof the needles, pledgets, suture spools, suture dispensers, and/or otherdevices disclosed herein.

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, devices, and systems should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The methods, devices, and systems are not limited to anyspecific aspect or feature or combination thereof, nor do the disclosedembodiments require that any one or more specific advantages be presentor problems be solved.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language. Forexample, operations described sequentially may in some cases berearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods can be used in conjunction with other methods.

As used herein, the term “and/or” used in a list of elements means anyone or more of the listed elements. For example, the phrase “A, B,and/or C” means “A,” “B,” “C,” “A and B,” “A and C,” “B and C” or “A, Band C.”

As used herein, the term “coupled” generally means physically linked anddoes not exclude the presence of intermediate elements between thecoupled items absent specific contrary language.

In view of the many possible embodiments to which the principlesdisclosed herein may be applied, it should be recognized that theillustrated embodiments are only preferred examples and should not betaken as limiting the scope of the disclosure. The scope of thisdisclose is at least as broad as the scope of the following claims. Itherefore claim all that comes with the scope of these claims.

What is claimed is:
 1. A suture spool assembly, comprising: a rigidouter housing; a first spool of suture material suspended within theouter housing such that the first spool is free to rotate relative tothe outer housing about a central axis of the first spool; and a firstsuture outlet in the outer housing through which a free end of thesuture material on the first spool extends, such that tension on thefree end of the suture material causes the first spool to rotate anddispense the suture material from the first spool through the firstsuture outlet.
 2. The assembly of claim 1, wherein the outer housingcomprises a handle portion that supports the first spool and a capportion that includes the first suture outlet.
 3. The assembly of claim2, wherein the cap portion is securable to the handle portion and thecap portion is removable from the handle portion to insert the firstspool into the handle portion or to remove the first spool from thehandle portion.
 4. The assembly of claim 1, wherein the first spoolcomprises: an outer body that is stationary relative to the outerhousing; and an inner body that carries the suture material and thatrotates within the outer housing.
 5. The assembly of claim 4, whereinthe inner body of the first spool includes a central axle defining thecentral axis, and the central axle projects laterally through openingsin the outer body of the first spool.
 6. The assembly of claim 4,wherein the outer body of the first spool includes a radial opening suchthat suture material passes from the inner body of the first spool,through the radial opening in the outer body of the first spool, andthrough the first suture outlet in the outer housing.
 7. The assembly ofclaim 1, further comprising:
 8. a second spool of suture materialsuspended within the outer housing such that the second spool is free torotate relative to the outer housing about a central axis of the secondspool.
 9. The assembly of claim 7, further comprising a second sutureoutlet in the outer housing through which a free end of the suturematerial on the second spool extends, such that tension on the free endof the suture material from the second spool causes the second spool torotate and dispense the suture material from the second spool throughthe second suture outlet.
 10. The assembly of claim 7, wherein thecentral axis of the first spool and the central axis of the second spoolare collinear.
 11. The assembly of claim 7, wherein the central axis ofthe first spool and the central axis of the second spool are notcollinear.
 12. The assembly of claim 7, wherein the suture material ofthe first spool and the suture material of the second spool aredifferent in diameter, substance, texture, color, or tensile strength.13. The assembly of claim 1, further comprising a cutting element thatcuts off a free end portion of the suture material outside of the outerhousing.
 14. The assembly of claim 1, wherein the housing is taperedfrom the first suture outlet along the central axis.
 15. A surgicalneedle comprising: an elongated rigid body having a sharp front end forpiercing and a rear end; and a flexible looped portion coupled to therear end of the rigid body; wherein the looped portion comprises foursubstantially linear segments linked together end-to-end with threebends joining the four linear segments such that the looped portion hasa generally quadrilateral shape in an open configuration; wherein thelooped portion is resiliently collapsible from the open configuration toa collapsed configuration where the four linear segments are generallyparallel and extending linearly from the rear end of the rigid body,such that the surgical needle is adapted to capture a suture between thefour linear segments in the collapsed configuration while the surgicalneedle is drawn through a target object; and wherein the looped portionis resiliently expandable from the collapsed configuration back to theopen configuration, such that the surgical needle is adapted to releasethe captured suture from between the four linear segments after thesurgical needle has drawn the suture through a target object.
 16. Thesurgical needle of claim 14, wherein the looped portion has a generallykite-shaped formation in the open configuration, wherein a first two ofthe four linear segments have substantially the same length, and asecond two of the four linear segments have substantially the samelength, and the first two linear segments have a different length thanthe second two linear segments.
 17. The surgical needle of claim 14,wherein the three bends each define an interior angle between the linearsegments joined by the respective bend, and wherein when the loopedportion is in the collapsed configuration, a first of the three bendshas an interior angle that is near 0° and the other two of the threebends have an interior angle that is near 180°.